Home NDC 57337-138-01 XtraCare Oatmeal Daily Moisturizing
Product NDC 57337-138
Requested package NDC 57337-138-01
11-digit product format 573370138
Labeler code 57337
Product ID 57337-138_2e12de28-f85b-9518-e063-6394a90ae58f
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Rejoice International Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-19
Substance DIMETHICONE
Active strength 1.3 g/100g
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57337-138 57337-138-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-138 57337-138-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-138 57337-138-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base XtraCare Oatmeal Daily Moisturizing
Brand name suffix 8 oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1.3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891710 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-138-01 XtraCare Oatmeal Daily Moisturizing8 oz 227 g in 1 BOTTLE, PUMP LOTION 227 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-138 XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ (DIMETHICONE) LOTION [REJOICE INTERNATIONAL INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250216_c055d5fb-7398-26e4-e053-2995a90acd41.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 45 of 68 · 1,350 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57337-138-01 57337013801 227 g in 1 BOTTLE, PUMP (57337-138-01) 227 g 2021-04-19 0000-00-00 No No Current